Published in a new report, the collaboration between Seda and Medicines Discovery Catapult (MDC) showcases the power of collective expertise in driving therapeutic innovation. This paper demonstrates the combined capabilities of Seda Pharmaceutical Development Services in the design, manufacture and physical characterisation of lipid nanoparticles for nucleic acid delivery, coupled with the advanced in vitro characterisation capabilities of MDC. Together, these organisations can support the design, prototype manufacture and screening of complex medicines ready for progression to preclinical in vivo testing and onwards to clinical development.

Nucleic acid (NA)-based therapeutics hold immense promise in treating a wide range of diseases, from genetic disorders to infectious diseases and cancer. The interplay between formulation and biological performance is more complex in NA-based therapies compared to conventional small molecule drug development and demands a range of expertise and methods of analysis. This white paper is the result of a partnership between MDC and Seda with the primary aim of showcasing their respective but complementary laboratory capability in elucidating this formulation/efficacy relationship.

In this study, siRNA-loaded liposomes (termed lipoplexes) and lipid nanoparticles (LNPs) were chosen as representative systems to investigate the influence of the manufacturing process of the lipid-based formulation on intracellular delivery. The design and manufacture, including process optimisation and physical characterisation, of both nanoparticle (NP) formulation types were performed by Seda. The biological performance of the NPs was assessed by MDC. Advanced microscopy techniques were used to demonstrate the kinetics of uptake, visualise intracellular trafficking and cytoplasmic delivery of siRNA by lipoplexes and LNPs.

From a complex parenteral medicines perspective, Seda offers robust capability for supporting a range of advanced drug delivery technologies, including liposomes, dendrimers, polymeric nanoparticles, micelles, inorganic and LNPs, and is experienced in navigating challenges regarding formulation stability, characterisation, manufacturing (process understanding and scale-up), and the associated regulatory pathways for clinical trials approval and marketing authorisation.

Partnering with us gives you access not only to our formulation design and manufacturing services but also to our network of internationally recognised collaborators for assessing the performance of nanoparticulate delivery systems.

Medicines Discovery Catapult offers a comprehensive complex medicine analytical platform, incorporating in vitro characterization (cell-specific binding, uptake and cellular delivery), in vivo biodistribution and efficacy, and ex vivo tissue analysis to measure tissue accumulation, penetration and target engagement.

Medicines Discovery Catapult (MDC) is an independent, not-for-profit innovation centre for drug discovery and part of the Catapult Network established by Innovate UK.

Seda is a member of MDC’s CRO Network and part of its Virtual R&D offering. Seda Pharmaceutical Development Services | Medicines Discovery Catapult

Read more about the capabilities of the Seda consultants, modellers and laboratory scientists in the field of complex medicines here Complex Medicines | Seda (sedapds.com)

Contact claire.patterson@sedapds.com today to learn more about how Seda’s Complex Medicines Services can propel your complex medicine development programme.